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Krystal Biotech Stock Up on FDA Nod to Vyjuvek Label Update
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Key Takeaways
Krystal Biotech gained FDA approval to expand Vyjuvek's label to DEB patients from birth.
The update allows at-home administration and flexibility in managing wound dressings.
Approvals in Europe and Japan, plus U.S. growth, are expected to boost Vyjuvek sales.
Krystal Biotech (KRYS - Free Report) announced that the FDA has approved a label update of its marketed product, Vyjuvek (beremagene geperpavec-svdt), to include dystrophic epidermolysis bullosa ("DEB") patients from birth.
Shares of Krystal Biotech were up 8.4% yesterday following the announcement of the news.
The latest update also gives patients greater flexibility in using Vyjuvek, including managing wound dressings. Patients and caregivers can now administer Vyjuvek themselves at home, making it more convenient.
The FDA label update was based on data from an open-label extension study in the United States as well as real-world experience with Vyjuvek, which supported the long-term safety and efficacy of the drug across patients of all ages.
In 2023, the FDA approved Vyjuvek as the first-ever revocable gene therapy for treating patients aged six months or older with DEB.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
KRYS’ Price Performance
Year to date, shares of Krystal Biotech have lost 0.7% against the industry’s increase of 3.6%.
Image Source: Zacks Investment Research
KRYS’ Vyjuvek Witnessing Encouraging Uptake
Krystal Biotech has made steady progress, securing access and reimbursement for Vyjuvek since its launch in the United States. As of July, Krystal secured over 575 reimbursement approvals for Vyjuvek in the United States.
The European Commission granted marketing authorization to Vyjuvek in April for treating wounds in patients with DEB who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.
The company is gearing up for the first European launch in Germany in the third quarter and in France in the fourth quarter of 2025.
Vyjuvek was also approved in July in Japan for the treatment of patients with DEB from birth. The company targets to launch the drug in Japan before the end of 2025.
Vyjuvek recorded sales worth $184.2 million during the first half of 2025. The latest label update in the United States, along with the recent approval in Europe and Japan, is likely to boost sales further in future quarters.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 54% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 97 cents. Loss per share estimates for 2026 have narrowed from 97 cents to 88 cents during the same period. ALLO stock has declined 46% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters while meeting the same on the remaining occasion, the average surprise being 14.03%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 118.1% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
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Krystal Biotech Stock Up on FDA Nod to Vyjuvek Label Update
Key Takeaways
Krystal Biotech (KRYS - Free Report) announced that the FDA has approved a label update of its marketed product, Vyjuvek (beremagene geperpavec-svdt), to include dystrophic epidermolysis bullosa ("DEB") patients from birth.
Shares of Krystal Biotech were up 8.4% yesterday following the announcement of the news.
The latest update also gives patients greater flexibility in using Vyjuvek, including managing wound dressings. Patients and caregivers can now administer Vyjuvek themselves at home, making it more convenient.
The FDA label update was based on data from an open-label extension study in the United States as well as real-world experience with Vyjuvek, which supported the long-term safety and efficacy of the drug across patients of all ages.
In 2023, the FDA approved Vyjuvek as the first-ever revocable gene therapy for treating patients aged six months or older with DEB.
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
KRYS’ Price Performance
Year to date, shares of Krystal Biotech have lost 0.7% against the industry’s increase of 3.6%.
Image Source: Zacks Investment Research
KRYS’ Vyjuvek Witnessing Encouraging Uptake
Krystal Biotech has made steady progress, securing access and reimbursement for Vyjuvek since its launch in the United States. As of July, Krystal secured over 575 reimbursement approvals for Vyjuvek in the United States.
The European Commission granted marketing authorization to Vyjuvek in April for treating wounds in patients with DEB who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.
The company is gearing up for the first European launch in Germany in the third quarter and in France in the fourth quarter of 2025.
Vyjuvek was also approved in July in Japan for the treatment of patients with DEB from birth. The company targets to launch the drug in Japan before the end of 2025.
Vyjuvek recorded sales worth $184.2 million during the first half of 2025. The latest label update in the United States, along with the recent approval in Europe and Japan, is likely to boost sales further in future quarters.
Krystal Biotech, Inc. Price
Krystal Biotech, Inc. price | Krystal Biotech, Inc. Quote
KRYS' Zacks Rank and Stocks to Consider
Krystal Biotech carries a Zacks Rank #4 (Sell) at present.
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 54% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 97 cents. Loss per share estimates for 2026 have narrowed from 97 cents to 88 cents during the same period. ALLO stock has declined 46% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters while meeting the same on the remaining occasion, the average surprise being 14.03%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 118.1% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.